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NCT04080284
Trial of Maintenance With Niraparib- Uterine Serous Carcinoma
Phase 2 trial testing Niraparib in Endometrial Cancer in 22 participants. Completed in 1 January 2025.
1 January 2025
Quick facts
| Lead sponsor | Northwell Health |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 30 December 2019 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 January 2025 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Niraparib (niraparib) — full drug profile →
Conditions studied
- Endometrial Cancer — all drugs for Endometrial Cancer →
- Papillary Serous Endometrial Carcinoma — all drugs for Papillary Serous Endometrial Carcinoma →
- Uterine Serous Carcinoma — all drugs for Uterine Serous Carcinoma →
- Endometrial Carcinoma — all drugs for Endometrial Carcinoma →
Sponsor
Northwell Health — full company profile →
Who can join
18 and older, female only, with Endometrial Cancer or Papillary Serous Endometrial Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Uterine serous carcinoma (USC) accounts for up to 40% of endometrial cancer-related deaths. Patients with USC share many genomic and clinical characteristics with patients who has serous ovarian cancer. The objective of this study is to evaluate the efficacy of maintenance Niraparib regimen in patients with advanced or platinum sensitive recurrent uterine serous carcinoma. Additionally, the investigators aim to further describe the safety of this regimen. The investigators hypothesize that Niraparib maintenance will be a well-tolerated treatment and show significant response in patients with uterine serous carcinoma.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
DNA Repair Pathways in Cancer Therapy and Resistance.
Li LY, Guan YD, Chen XS, Yang JM, et al · · 2020 · cited 254× · PMID 33628188 · DOI 10.3389/fphar.2020.629266 -
PARP Inhibitors in Endometrial Cancer: Current Status and Perspectives.
Musacchio L, Caruso G, Pisano C, Cecere SC, et al · · 2020 · cited 33× · PMID 32801862 · DOI 10.2147/cmar.s221001 -
PARP inhibitors and immunotherapy in ovarian and endometrial cancers.
Miller RE, Lewis AJ, Powell ME. · · 2021 · cited 9× · PMID 33882241 · DOI 10.1259/bjr.20210002 -
PARP inhibitors in non-ovarian gynecologic cancers.
Fernandes I, Chehade R, MacKay H. · · 2024 · cited 2× · PMID 38882441 · DOI 10.1177/17588359241255174
Verify or expand the search:
- PubMed search for NCT04080284
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Niraparib
Trials testing the same drug.
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- NCT06682780 — A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours · Phase 1, PHASE2 · recruiting
- NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting
- NCT06887933 — A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ov · Phase 4 · not yet recruiting
- NCT05672095 — Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer · Phase 1, PHASE2 · withdrawn
Other recruiting trials for Endometrial Cancer
Currently open trials in the same condition.
- NCT07419841 — A Phase 1 Study of the Safety and Tolerability of CTX-10726 · Phase 1 · recruiting
- NCT07382583 — Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the P · recruiting
- NCT07377734 — Intrauterine Injection of Type III Collage in FST of EC/AEH · Phase 2 · recruiting
- NCT07319429 — Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification · Phase 2, PHASE3 · recruiting
- NCT07397624 — Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer · recruiting
Other Northwell Health trials
Trials by the same sponsor.
- NCT07253662 — Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Aden · Phase 1 · recruiting
- NCT07191041 — Emotional Urinary Tract Infection · not yet recruiting
- NCT07254091 — Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Pancreatic Cancer · EARLY_PHASE1 · recruiting
- NCT07344961 — Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB) · recruiting
- NCT07193862 — Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Meta · EARLY_PHASE1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04080284 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Northwell Health
- Last refreshed: 19 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04080284.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing